Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine

This study is currently recruiting participants.
Verified December 2013 by Hopital Lariboisière
Sponsor:
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT01813292
First received: March 12, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

HIV+ patients are considered at risk for excessive bone fragility. Several factors could contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality.

The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months. The patients will be randomly selected, then matched according to age, ethnic origin, BMI.


Condition
HIV+

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparative Study of Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV + Men Being Given Tenofovir With FTC, Emtricitabine (TRUVADA®), or Without (VIREAD®), as Part of Their Antiretroviral Therapy.

Resource links provided by NLM:


Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:
  • Areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius measured by Dual X-ray absorptiometry (DXA) [ Time Frame: ongoing, during the study period, according to the availability of DXA ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine, bone remodelling by measurement of P1NP. Dual X-ray absorptiometry (DXA) will be used to determine the areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius. Volumetric BMD (v-BMD) and micro-architecture of distal radius and tibia will be studied using a HR-pQCT scan (Xtreme, Scanco).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months.

Criteria

Inclusion Criteria:

  • HIV+ patients
  • male patients
  • patients treated by tenofovir+emtricitabine(TRUVADA®) or tenofovir(VIREAD®) for more than 60 months.

Exclusion Criteria:

  • chronic use of fluoroquinolones, antifungal agents, steroids
  • malignancy (current or previous) requiring chemotherapy or radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01813292

Locations
France
Hopital Lariboisiere Recruiting
Paris, France, 75475
Contact: Pierre O Sellier, MD, PhD    00 33 149956339    pierre.sellier@lrb.aphp.fr   
Principal Investigator: Pierre O Sellier, MD, PhD         
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Principal Investigator: Pierre O Sellier, M.D, Ph.D Hopital Lariboisiere, Paris, France
  More Information

No publications provided

Responsible Party: Stephane Mouly, MD PhD, Professor, Medicine A Department,, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT01813292     History of Changes
Other Study ID Numbers: URT-Bone-001
Study First Received: March 12, 2013
Last Updated: December 5, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hopital Lariboisière:
male patients
treated by TRUVADA® or VIREAD® for more than 60 months

Additional relevant MeSH terms:
Fluorides
Tenofovir
Emtricitabine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 15, 2014